Kornimate/medical-research-clean huggingface dataset:
ascending dose study of the safety and tolerability of alirocumab (sar236553/regn727) in japanese healthy volunteers

Conditions: Hypercholesterolemia

Summary: primary objective: to assess the safety and tolerability of ascending single doses of subcutaneously (sc) administered alirocumab (sar236553/regn727) in japanese healthy male subjects. secondary objectives: * to assess the pharmacodynamics effect of a single sc dose of alirocumab on serum low-density lipoprotein cholesterol (ldl-c) and other lipids and apolipoproteins such as total cholesterol, high-density lipoprotein cholesterol (hdl-c), non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, triglycerides, apolipoprotein b, apolipoprotein a1 and lipoprotein(a). * to assess the pharmacokinetic profile of a single sc dose of alirocumab. * to assess the immunogenicity of a single sc dose of alirocumab.

4 sequential dose cohorts. single dose followed by a total observation period of 15 weeks (106 days) for each participant.

Eligibility criteria:
inclusion criteria: * healthy male subject, between 20 and 65 years inclusive. * body weight between 50.0 and 95.0 kg inclusive, body mass index between 18.0 and 30.0 kg/m² inclusive. * serum ldl-c levels \>100 mg/dl exclusion criteria: * subject indicated for the use of statins according to criteria in adult treatment panel (atp) iii guidelines as updated in 2004 * significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, dermatological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study. * history or presence of drug or alcohol abuse * smoking more than 5 cigarettes or equivalent in any 24 hour period. * any medication (including st john's wort) within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic (pd) half-life of that drug, whichever the longest; any vaccination within the last 28 days. * positive reaction to any of the following tests: hepatitis b surface (hbs ag) antigen, anti-hepatitis b core antibodies (anti-hbc ab), anti-hepatitis c virus (anti-hcv) antibodies, human immunodeficiency virus (hiv) antigen and antibodies, syphilis. * elevated cholesterol due to a secondary cause such as hypothyroidism or alcohol. * presence or history of drug hypersensitivity * initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening. * initiation of a new diet or major change to a previous diet within 4 weeks prior to screening. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
evaluation of efficacy and safety of long-acting risperidone microspheres in patients with schizophrenia or other psychotic disorders when switching from typical antipsychotic (oral/depot) or atypical oral other than risperidone

Conditions: Schizophrenia, Catatonic; Schizophrenia, Disorganized; Schizophrenia, Paranoid; Schizophrenia; Psychotic Disorders

Summary: the purpose of this study is to evaluate the efficacy, tolerability and safety of patients on long-acting risperidone microshpheres injection. the major advantage of long-acting injection over oral medication is facilitation of compliance in medication taking. non-compliance is very common among schizophrenic and is a frequent cause of relapse.


Eligibility criteria:
inclusion criteria: * subjects with schizophrenia or another psychotic disorder according to dsm iv criteria who requires long term antipsychotic therapy * currently treated with either an atypical antipsychotic, other than risperidone, a conventional depot antipsychotic or oral conventional antipsychotic * subject has been symptomatically stable on a stable dose of an antipsychotic the last month * subject and/or patient's relative, guardian or legal representative has signed the informed consent form exclusion criteria: * first antipsychotic treatment ever * on clozapine during the last 3 month * serious unstable medical condition * history or current symptoms of tardive dyskinesia * history of neuroleptic malignant syndrome * pregnant or breast-feeding female * female patient of childbearing potential without adequate contraception. * participation in an investigational drug trial in the 30 days prior to selection * known intolerance/non-responder to risperidone

Keywords: catatonic schizophrenia disorganized schizophrenia paranoid schizophrenia undifferentiated schizophrenia schizo-affective disorders
use of pcr-sars-cov-2 in children

Conditions: Covid-19

Summary: the vigil study was set up at the beginning of the pandemic, in the spring of 2020, at a time when diagnostic testing for sars-cov-2 had to be performed according to specific clinical criteria (even if no clinical picture suggestive of covid had been clearly identified). the management of sick young children (with respiratory tract infection that could be attributed to covid) by pediatricians (infectious diseases specialists, emergency physicians, general practitioners, and outpatients) was facilitated by an algorithm whose objective was to help define the indications for sars-cov-2 pcr and subsequently for antigenic testing. the current technique of deep nasopharyngeal swabbing (for pcr or antigenic testing) is delicate and difficult in children, and is therefore a serious handicap for community-based screening, especially since infectious episodes are frequent in children. since then, nasal self-tests that can be easily used in children have been commercialized and have facilitated screening. because of the similarity between the clinical signs of respiratory tract infections in children, it is often impossible to distinguish between different viral respiratory infections and epidemics may overlap in time. however, the identification of the pathogen is the key to improve management of these infectious diseases. the vigil study is therefore continuing, still facilitated by the existence of an active pediatric network existing for 20 years. activ afpa and gpip have created networks of hospital and ambulatory pediatricians who actively participate in various observatories https://www.jpeds.com/article/s0022-3476(17)31606-2/fulltext to date, these observatories have resulted in the publication of more than 80 articles in international journals (https://www.activ-france.com/fr/publications).


Eligibility criteria:
inclusion criteria: * children under 15 years of age * prescription of a pcr-sars-cov-2 * vigil information note given to parents exclusion criteria: * refusal to participate by the patient, family member or legal representative (depending on the situation)
observation of long-term effects on endometrium and uterine fibroids in women with ulipristal acetate therapy

Conditions: Myoma; Uterine Bleeding, Dysfunctional; Uterine Bleeding Heavy; Dysmenorrhea; Endometrium Hyperplasia

Summary: a prospective observational study on italian women undergoing ulipristal acetate (upa) therapy for symptomatic myomas and its impact on symptomatology and moreover on myomas architecture. we also evaluate changes in the endometrial pattern of selected women.


Eligibility criteria:
inclusion criteria: * number of myomas from 1 to 4 * heavy menstrual bleeding * conservative treatment request exclusion criteria: * concurrent endometrial pathology * post-menopausal status * hepatic pathology * endocrine or metabolic disorders

Keywords: ulipristal acetate myoma leiomyoma endometrial patterns symptomatology
intraspinal pressure monitoring for acute traumatic spinal cord injury: a validation study

Conditions: Spinal Cord Injuries; Spine Injury

Summary: intraspinal pressure monitoring has been advanced as a potential technique for evaluating spinal cord perfusion after traumatic spinal cord injury. in this study, the investigators aim to validate the technique for insertion of a fiberoptic pressure monitoring device in the subarachnoid space at the site of injury for measurement of intraspinal pressure and spinal cord perfusion pressure. the primary objective of this study is to validate the methodology of invasive intraspinal pressure monitoring to derive parameters for optimal spinal cord perfusion pressure, spinal cord reserve capacity and spinal reactivity index using data obtained during the patient's stay in the intensive care unit. secondary objectives of this study will be to a) evaluate the safety of invasive intraspinal pressure monitoring, b) prospectively evaluate the overall relationship between spinal cord perfusion pressure and functional outcomes in patients with acute traumatic spinal cord injury and c) evaluate the relationship between spinal cord perfusion pressure, motor evoked potentials and functional outcomes after incomplete spinal cord injury.


Eligibility criteria:
inclusion criteria: * • patients with acute traumatic spinal cord injury asia a, b or c * age between 18-70yrs exclusion criteria: * patients with central cord syndrome * patients presenting to hospital \>48hrs from time of spinal cord injury * patients unable to communicate in english language * pre-existing cognitive impairment * penetrating spinal cord injury * pre-existing neurodegenerative disorder involving brain or spinal cord * patients with concomitant injuries requiring emergent surgical intervention

Keywords: spinal cord perfusion pressure spinal cord injury intraspinal pressure spinal reactivity
effect of continuous anterior chest compression on ventilation/perfusion ratio and hemodynamics

Conditions: Acute Respiratory Distress Syndrome

Summary: intro: the mortality of acute respiratory distress syndrome (ards) remains high (40%), and may be aggravated by ventilation-induced lung injury (vili), the main mechanisms of which are: 1. anterior region overdistension, 2. atelectrauma in the posterior regions. positive expiratory pressure (peep) adjusted on the ventilator during ards aims to recruit posterior pulmonary territories in order to limit atelectrauma but is accompanied by a concomitant risk of overdistension of anterior territories. recent data suggest that continuous anterior chest compression (cacc) could limit the overdistension of the anterior regions by decreasing the compliance of the anterior chest wall and thus the regional transpulmonary pressure, while promoting the redistribution of ventilation to the posterior territories. the effects of ccac on ventilation/perfusion ratios and hemodynamics are unknown. hypothesis/objective : the participants hypothesize that during ards, ccac: 1. improves ventilation/perfusion ratios by decreasing both anterior territory dead space effect and posterior territory shunt, 2. induce an improvement in cardiac output by decreasing right ventricular afterload (decrease in capillary compression related to the overdistension of the anterior territories and decrease in hypoxic vasoconstriction of the condensed territories). objective: primary outcome : to evaluate the effects of ccac on ventilation/perfusion ratios during moderate to severe ards. secondary outcome : to evaluate the effects of ccac on hemodynamics : left heart morphology, systolic and diastolic function, cardiac output, right heart morphology, systolic function, pulmonary hypertension, volemia. method in patient with moderate to severe ards, cacc is performed manually and the pressure applied will be maintained between 60 and 80 cmh2o. electrical impedance tomography of ventilation and perfusion will be used for the measurement of the percentage of areas with normal va/q ratios, areas of shunt and areas of dead space effect. left heart morphology, systolic and diastolic function, cardiac output, right heart morphology, systolic function, pulmonary hypertension, volemia will be evaluated by using echocardiography.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * ards moderate to severe according to the berlin criteria * patient receiving continuous sedation and curarization * free and informed consent from the patient or family member exclusion criteria: * pregnancy * adult patient subject to a legal protection measure (tutor, curator, etc.) * patients with a pacemaker, automatic implantable cardioverter defibrillator, * contraindications to thoracic belt placement (e.g., thoracic or spinal cord trauma, recent thoracic surgery) * undrained pneumothorax, bronchopleural fistula * hemodynamic instability (i.e., use of intravenous fluids of more than 10 ml/kg or vasopressors 2 mg/h of norepinephrine or 0.5 mg/h of epinephrine)

Keywords: ards cardiac output ventilation perfusion ratio
pain processing in relation to breathing

Conditions: Central Sensitisation; Pain

Summary: the goal of this clinical trial is to investigate the effect of breathing on the processing of experimental pain in healthy participants. the main questions are: 1. does breathing rate influence the spatial extent of thermally induced secondary hyperalgesia, a proxy of central sensitization? 2. does resonance frequency breathing influence the autonomic nervous system, compared to baseline and compared to paced breathing at a natural frequency? 3. is spinal excitability, measured using the magnitude of the nociception withdrawal reflex (nwr), affected by resonance frequency breathing, compared to paced breathing at a natural frequency? participants: * will receive heat stimuli * 's skin's sensitivity will be tested using quantitative sensory testing tools. * will receive various instructions on the speed of their breathing * 's heart rate, respiratory rate and sweat response will be measured * will fill in questionnaires researchers will compare the spatial extent of sensitivity resulting from application of heat stimuli during paced resonance frequency breathing compared to paced breathing at a natural frequency to see if the breathing rhythm influences central sensitization processes.


Eligibility criteria:
inclusion criteria: 1. over 18 and below 40 years of age 2. good general health 3. able to give informed consent exclusion criteria: 1. any major medical or psychiatric condition (e.g. heart disease, diabetes, autoimmune disorders, infectious diseases, major depressive disorder), any chronic pain condition, any respiratory problems, any current acute pain at time of study 2. inability to follow study instructions, e.g. due to language problems 3. consumption of alcohol, drugs, analgesics within the last 24 h 4. consumption of no more than 100 mg of caffeine within the last 8 h 5. scar tissue or generally reduced sensitivity in the designated testing site areas additional exclusion criteria for experiments 3 and 4 1. shoe size \< 38 2. restless-legs-syndrome
the debridement to treat the traumatic corneal abrasion

Conditions: Corneal Abrasion

Summary: patients who signed informed consent to participate in the study will receive corneal epithelial deplasia. the patient was instructed to follow up closely in the following year, and the recurrence of the patient was collected through wechat follow-up.

traumatic corneal abrasion (tca) refers to the injury or defect of the corneal epithelium caused by a foreign object (such as a nail, a tree branch, etc.), which is characterized by severe eye pain accompanied by red eyes, blepharospasm, photophobia, tearing, and a distinct foreign body sensation. tca is one of the common eye injuries and ophthalmic emergencies, accounting for about 5%-10% in ophthalmic emergencies. methods: the investigators conducted a clinical trial in adult patients with corneal trauma at the zhongshan ophthalmology center of sun yat-sen university. patients who signed informed consent to participate in the study were provided with corneal epithelial debridement. patients were instructed to follow closely for the following year, and a pain log of the patient was collected at the last ophthalmology clinic visit.

Eligibility criteria:
inclusion criteria: 1. the affected eye is traumatic corneal epithelial abrasion, and the specific criteria are as follows: a: damage caused by one of the three high risk causes of recurrent corneal epithelial exfoliation defined as fingernails, paper, or plant leaves; b: monocular disease; c: eye pain, tears, photophobia and foreign body sensation when injured; d: local defect of corneal epithelium was found at the time of injury, and fluorescein sodium staining was positive; e: the time from injury to first diagnosis is less than 24 hours. 2. be between the ages of 18 and 60. 3. patients volunteered to participate in the study and signed the informed consent, showing good compliance. exclusion criteria: 1. corneal epithelial defect complicated with infection. 2. patients with other ocular surface diseases (such as eyelid insufficiency, eyelid gland dysfunction, sjogren's syndrome, bullae keratopathy, corneal dystrophy, drug induced corneal toxicity, etc.). 3. pre-existing corneal disease (corneal degenerative disease or viral keratitis, etc.) or history of corneal surgery; 4. long-term contact lens wearers. 5. pregnant or lactating women; severe impairment of heart, liver and kidney function; one who is mentally abnormal; people with other inflammatory or autoimmune diseases. corneal epithelial defect complicated with infection
comparative study about the impact of two oil emulsions administered intravenously on severe acute pancreatitis

Conditions: Severe Acute Pancreatitis

Summary: the purpose of this study is to comparatively assess the potential antiinflammatory effects of intravenous lipid emulsions rich in omega 3 polyunsaturated fatty acids and olive oil versus intravenous lipid emulsions made exclusively with mct and lct on the evolution of patients with severe acute pancreatitis during the period in needing artificial nutrition support with total parenteral nutrition so unique.

information recorded in other data elements.

Eligibility criteria:
inclusion criteria: * diagnosis of acute pancreatitis: characteristic abdominal pain, serum amylase and / or lipase \>= 3 times the upper limit of normal range, characteristic ct-scan * criteria of severity of acute pancreatitis diagnosed at \ = grade d, apache-ii \>= 8, c-reactive protein \>= 150 mg/l * inability to initiate feeding (oral or with nutritional supplements) and / or enteral nutrition during the 5 days after the diagnosis and prediction of the indication of nil-by-mouth \>= 5 days * \<= 3 mmol/l of triglycerides in the blood * men and women aged \>= 18 years old * acceptance of informed consent exclusion criteria: * known hipersensitivity to the fish, egg or soy proteins * lipid etiology * \> 3 mmol/l of triglycerides in the blood * severe hepatic impairment * severe renal insufficiency without dialysis or haemofiltration * serious disturbances of blood clotting * acute shock * infusion therapy general contraindications * clinical conditions of instability that must not be taken with parenteral nutrition * have other acute or chronic inflammatory diseases * status of severe immunosuppression: cytotoxic treatment in 15 days prior to inclusion and / or a disease that causes white blood cells levels \<5000/mm3 * treatment with steroids \> 0.25 mg/kg/day of prednisone or equivalent doses of corticosteroids: as pre-treatment and / or during admission

Keywords: severe acute pancreatitis total parenteral nutrition fat emulsions omega 3 fatty acids
impact of listening to low tones on motor function in children with cp

Conditions: Cerebral Palsy; Hypertonia

Summary: the study aims to evaluate the impact of a possible new treatment for hypertonia, contributing to the motor disability in children with cerebral palsy (cp). this study follows a 2005-2006 pilot study, that demonstrate a significant motor improvement in 4 children exposed to low tones via stereophonic headphones.(a possible mechanism is a deep brain stimulation outspreading from the auditory pathways in certain tones) the goal of this study is to perform a double blind randomized placebo-controlled trial (rct) on 30 children. a three-arm study, with one group receiving the proposed treatment-music with low tones and the other two groups receiving a placebo (music without tones or stories) will be performed. clinical and a non invasive laboratory measurements (surface emg) related to spasticity, active and passive range of movement, isometric strength and upper and lower body function would be measured both before and after the treatment .the assessments will include also a visual assessment , evaluation of gaze coordination and a quality of life and a caretaker burden questionnaires.

a pilot study we had done this year demonstrate a significant improvement in spasticity as measured clinically and by non invasive surface emg, in four children with hypertonic cp, exposed to music combined with low frequency tones, via stereophonic headphones. two children demonstrated a prompt motor improvement also. the goal of this study is to perform a double blind randomized placebo-controlled trial (rct) to assess these preliminary results. participants: 30 children with moderate to severe hypertonic cp (gmfcs 3-5), aged 3-9 years, from the "meshy" or "ilanot" early childhood development centers - jerusalem, israel, will be recruited with parents informed consent. children who refuse to put on the headphones will not be included. a randomized controlled three-arm study, with one group receiving the proposed treatment-music with low tones and the other two groups receiving a placebo (music without tones or stories) will be performed. the children will listen to the music / stories via stereophonic headphones for 10 minutes - 3 times a week for 4 weeks. before starting the treatment the children will undergo: 1. neurological evaluation with their medical charts. 2. physiotherapic evaluation using the gmfm assessment and a surface emg 3. fine motor assessment using the quest and visual assessments. 4. parents will complete the podci and the care and comfort questionnaires. we will repeat the emg measurements immediately after the treatment. 3 months after completing the treatment we will repeat the measurements we had done before treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hypertonic cerebral palsy * ages 3-12 years exclusion criteria: * refusal to put on headphones